Lyne Laboratories
Form 483 issued October 21, 2022 · Brockton, Massachusetts
- Inspection
- Oct 12 – Oct 21, 2022
- Investigator
- Daniel L. Zheng
- Observations
- 7
- Pages
- 7
- FEI number
- 1000513191
In short: On October 21, 2022, FDA issued a Form 483 with 7 observations to Lyne Laboratories in Brockton, Massachusetts (FEI 1000513191) after an inspection that ran Oct 12 – Oct 21, 2022. The investigator was Daniel L. Zheng. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Yom firm failed to establish adequate written procedmes for production and process controls designed to assure…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Daniel L. Zheng
24 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmLyne Laboratories history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lyne Laboratories?
FDA listed 7 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Lyne Laboratories?
Daniel L. Zheng is named on this Form 483, for the inspection of Oct 12 – Oct 21, 2022. Each investigator has a profile showing what they cite most.
When was Lyne Laboratories inspected by FDA?
The inspection ran Oct 12 – Oct 21, 2022, and the Form 483 is dated October 21, 2022.
How do I get the full Form 483 for Lyne Laboratories?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.